Investigation of Pancreaticoduodenectomy

A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy

The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Study Overview

• Status: Completed
• Conditions: Pancreaticoduodenectomy

Detailed Description

For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

• Study Type: Observational
• Enrollment (Actual): 10085

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Description

Inclusion Criteria:

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
pancreaticoduodenectomy; patients underwent pancreaticoduodenectomy in recent ten years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Pancreatic Fistula(POPF)	The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	The time of operation count by minute.	Intraoperative
Mortality	The death occurred within 30 days after surgery	Within 30 days after surgery
Length of hospital stay after surgery	Days between surgery and hospital discharge	From first day after surgery to release from hospital (anticipate 5 days minimally)
Morbidity	The incidence of operative complications within 90 days after surgery	Within 90 days after surgery
Hospital costs	The total hospitalization expenses	From first day after surgery to release from hospital (anticipate 5 days minimally)

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: C201812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No